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Chemsherpa 管理対象物質 Ver2.02.00 説明書

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Chemsherpa 管理対象物質 Ver2.02.00 説明書 chemSHERPA 管理対象物質 Ver2.02.00 説明書 chemSHERPA 事務局 内容 1. はじめに ....................................................................................................................................... 2 2. 管理対象物質リストに関わる用語の定義 ....................................................................................... 3 3. 管理対象物質 Ver2.02.00 について............................................................................................ 4 3.1 管理対象基準 ..................................................................................................................... 4 3.1.1 LR01: 日本 化審法 第一種特定化学物質 ................................................................. 5 3.1.2 LR02︓米国 有害物質規制法（Toxic Substances Control Act︓TSCA）使用禁止 または制限の対象物質（第 6 条） .............................................................................................. 5 3.1.3 LR03︓EU ELV 指令 2000/53/EC ........................................................................... 6 3.1.4 LR04︓EU RoHS 指令 2011/65/EU ANNEX II ..................................................... 6 3.1.5 LR05︓EU POPs 規則 (EU) 2019/1021 ANNEX I ............................................... 7 3.1.6 LR06︓EU REACH 規則 (EC) No 1907/2006 Candidate List of SVHC for Authorisation（認可対象候補物質）および ANNEX XIV（認可対象物質） ........................... 7 3.1.7 LR07︓EU REACH 規則 (EC) No 1907/2006 ANNEX XVII（制限対象物質） . 10 3.1.8 LR08: 欧州 医療機器規則 Annex I 10.4 化学物質 ............................................. 10 3.1.9 IC01︓Global Automotive Declarable Substance List (GADSL) ....................... 11 3.1.10 IC02 ︓ IEC 62474 DB Declarable substance groups and declarable substances ..............................................................................................................................11 3.2 検索用物質リスト ................................................................................................................ 12 3.2.1 各法規制・業界基準の対象物質の抽出 ....................................................................... 12 3.2.2 化学物質群についての個別物質への展開 ..................................................................... 15 3.2.3 独自番号の付与 ......................................................................................................... 20 3.3 利用上の注意 .................................................................................................................... 21 4. Ver2.01.00 からの更新内容 ..................................................................................................... 22 4.1 管理対象基準の更新 ......................................................................................................... 22 4.2 各管理基準の更新 ............................................................................................................. 22 4.3 管理対象基準の更新内容とそれに伴う検索用物質リストの変更 ............................................. 22 4.4 検索用物質リスト作成に利用する展開リストの更新状況 ........................................................ 27 4.5 その他の変更点 .................................................................................................................. 31 付属 A 独自番号付与物質一覧 付属 B リクエストによる追加収載物質一覧 1 1 はじめに 1. はじめに chemSHERPA では、管理対象物質を管理対象基準の法規制・業界基準の対象となる化学物質の和集 合によって規定しています。また、管理対象基準として選定された法規制及び／又は業界基準において指定され ている物質群及び物質について、実用的に利用される範囲で物質群名表示の部分も含めて個別の物質名や CAS 番号 1まで展開したリスト（以降、「管理対象物質検索用リスト」という。）を作成しています。 chemSHERPA の管理対象物質は、以下のような状況を反映して更新管理しています。 ・管理対象基準の追加・変更 ・管理対象基準として選定された各法規制・業界基準の更新 ・物質群についての個別物質名への展開の見直し 本書は、管理対象物質 Ver2.02.00 の内容および、前版からの更新内容、リストの利用に関する注意事項 などを記載したものです。 なお、管理対象物質検索用リストは、データ作成支援ツールで利用していますが、リスト自体は公開していませ ん。ご希望の方には、有償でご提供しています。また、各管理対象基準における対象物質は、参照リストとして公 開しています。 また、検索用物質リストには、各法規制・業界基準の対象物質が化学物質群の場合、個別の物質に展開し て収載していますが、これについて、完全な物質展開を目指しているものではありません。本リストに収載されてい ない物質でも管理対象物質になる場合がありますことをご理解の上、ご利用ください。 ＜免責事項＞ chemSHERPA は、管理対象物質検索用リストの所有および利用によって生じた損害について、一切の責任 を負うものではありません。 1 本書に記載する”CAS 番号”は、CAS RN®のことを示しています。 2 2 管理対象物質リストに関わる用語の定義 2. 管理対象物質リストに関わる用語の定義 管理対象物質リストに関わる用語の定義は以下のとおりです。 用語 定義 製品含有化学物質 製品中に含有されることが把握される化学物質（JIS Z 7201:2017） 管理対象物質 chemSHERPA が法規制及び／又は業界基準を選択することで、製品 含有化学物質管理の対象とする化学物質 管理対象基準 管理対象物質を規定する元となる法規制及び／又は業界基準 参照リスト 管理対象基準として選定された法規及び／又は業界基準において 指定されている物質(群)を集約したリスト。なお、参照リストは chemSHERPA のホームページにて無償で公開しているほか、デ ータ作成支援ツールに同梱して配布している。 管理対象物質検索用リスト 管理対象基準として選定された法規制及び／又は業界基準におい （検索用物質リスト） て指定されている物質(群)を、実用的に利用される範囲で個別の CAS 番号に展開し、各管理対象基準との関連付けを示したもの。 データ作成支援ツールおよび製品含有化学物質の情報伝達で利用 される。なお、本検索用物質リストは原則非公開であり、有償で 提供している。 CAS 展開 管理対象基準が規制する物質のうち、CAS 番号が特定されていない場合 に、規制内容に適合すると考えられる CAS 番号を特定すること。管理対 象物質検索用リストとして使用する。 3 3 管理対象物質 Ver2.02.00 について 3. 管理対象物質 Ver2.02.00 について 3.1 管理対象基準 chemSHERPA 管理対象物質 Ver2.02.00 では、管理対象基準として、表 3-1 に示す 8 つの法令と２ つの業界基準を採用しています。それぞれの基準についての対象範囲は、表 3-1 の通りです。 なお、管理対象基準は、chemSHERPA 管理対象物質は下記のような考え方に基づいて設定されており、ニ ーズ等に応じて見直しを行います。 ［管理対象基準の選定の考え方］（物質リスト運用ルールより抜粋） □chemSHERPA 製品含有化学物質情報伝達スキームでは、 サプライチェーンにおける製品含有規制物質の情報伝達の確実化・円滑化のために、 サプライチェーン全体が必要とし、サプライチェーン全体で合意できる管理対象基準を選定することを目指す。 ［管理対象基準の選定（全般）］ □製品の含有規制に関係のある、法規制及び／又は業界基準から管理対象基準を選定する。 □法規等の内容（条件、表現、判断基準など）については変更せずに採用する。 表 3-1 管理対象物質 Ver2.02.00 の管理対象基準 管理対象基準 ID (略記 Ver2.02.00 の対象範囲 対象とする法規制及び業界基準名称 号) ※1 LR01 CSCL (日本) 化審法 第一種特定化学物質 2018-04-01 (米国) 有害物質規制法（TSCA） 使用禁止または制限物質（第 6 LR02 TSCA 40 CFR 763 条） LR03 ELV (EU) ELV 指令 2000/53/EC LR04 RoHS (EU) RoHS 指令 Annex II (EU) 2015/863 LR05 POPs (EU) POPs 規則 Annex I （EU）2020/784 (EU) REACH 規則 Candidate List of SVHC for Authorisation（認 C:2020-06-25, LR06 SVHC 可対象候補物質）および Annex XIV（認可対象物質） A:(EU) 2020/171 (※2) REACH (EU) REACH 規則 Annex XVII（制限対象物質） LR07 Annex (EU) 2019/1148 XVII (EU) 医療機器規則（MDR）Annex I 10.4 化学物質 CLP:(EU) 2020/217, LR08 MDR SVHC: 2020-06-25, BPR:- Global Automotive Declarable Substance List (GADSL) 2020 GADSL Reference IC01 GADSL List Version 1.0 IEC 62474 DB Declarable substance groups and declarable IEC62474 IC02 IEC624 74 substances D20.00 ※1 法令については、物質の追加/削除に関係する最新官報番号または日付を記載対象としています。対象範囲に記載された官 報番号または日付または番号の内容までを考慮して物質リストを作成しています。 4 3 管理対象物質 Ver2.02.00 について ※２Ｃは認可対象候補物質の公表日、A は認可対象物質に関する官報番号を示しています。 3.1.1 LR01: 日本 化審法 第一種特定化学物質 (1) 概要 日本の化学物質の審査及び製造等の規制に関する法律（通称 「化審法」）の第一種特定化学物 質。第一種特定化学物質は、難分解、高蓄積、人または高次捕食動物への長期毒性があるものとして 政令で定められており、製造、輸入、使用の原則禁止（許可制）、政令指定製品の輸入禁止などの管 理措置がとられている。経済産業省、環境省、厚生労働省の所管。 (2) 更新 不定期。官報で公示される。 (3) chemSHERPA での物質の区分 特になし（データ作成支援ツールでは、当該物質の LR01 の欄に“１”が表示される）。 (4) 法規における閾値と chemSHERPA の成分情報の閾値の考え方 法規上は、第一種特定化学物質の製造、輸入、使用は原則禁止されており、特に閾値は設定されて いない。ただし、副生成物として他の化学物質に微量含有される場合は、「利用可能な最良の技術（Ｂ ＡＴ︓Best Available Technology/Techniques）」を適用し、その含有割合が工業技術的・経済 的に可能なレベルまで低減していると認められるときは、当該副生成物は第一種特定化学物質として取り 扱わないものとするとされている。 chemSHERPA の成分情報の報告における閾値は“０”と考える。非意図的な添加で、BAT 又は経 済産業省が認めた自主管理値未満の場合は、その旨をコメント欄等で報告する。 (5) 参考 URL http://www.meti.go.jp/policy/chemical_management/kasinhou/about/class1spec ified_index.html 3.1.2 LR02：米国 有害物質規制法（Toxic Substances Control Act：TSCA）使用禁 止または制限の対象物質（第 6 条） (1) 概要 米国の有害物質規制法（Toxic Substances Control Act︓TSCA）の化学物質および混合物 の優先順位付け、リスク評価、および規制（第 6 条）の規制対象物質。これらの物質は化学物質およ びその混合物の製造、輸入、加工、流通、廃棄などの過程で人の健康や環境に不当なリスクをもたらす恐 れがあるとして、製造、加工流通の禁止や制限などの措置が適用されている。環境保護庁（US Environmental Protection Agency）の所管。 (2) 更新 不定期。 (3) chemSHERPA での物質の区分 特になし（データ作成支援ツールでは、当該物質の LR02 の欄に“１”が表示される）。 (4) 法規における閾値と chemSHERPA の成分情報の閾値の考え方 法規上は、物質ごとにリスク管理策が詳細に規定されている。当該物質の使用や、作業等が禁止され ており、chemSHERPA の成分情報の報告における閾値は“０”と考える。 (5) 参考 URL http://www.epa.gov/assessing-and-managing-chemicals-under-tsca/limitations- manufacturing-processing-and-use-tsca 5 3 管理対象物質 Ver2.02.00 について 3.1.3 LR03：EU ELV 指令 2000/53/EC (1) 概要 EU の使用済み車両（End-of-life vehicles)からの廃棄物の低減、適正処理を規定している ELV 指令（正式名称は、“Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of life vehicles”）の第 4 条で 2003 年 7 月 1 日以 降に市場に出る自動車部品や自動車製造用の材料に含まれることが禁止（ただし、Annex II に適用 除外用途あり）されている物質。 (2) 更新 不定期。 (3) chemSHERPA での物質の区分 特になし（データ作成支援ツールでは、当該物質の LR03 の欄に“１”が表示される）。 (4) 法規における閾値と chemSHERPA の成分情報の閾値の考え方 法規においては、最大許容濃度が均質材料中の重量比で 0.1%(カドミウムは 0.01%)と定められてい る。 chemSHERPA の成分情報における閾値は、法規の閾値（カドミウムについては 0.01%、その他は 0.1%を超える場合を禁止）と自主基準のうち、小さい方である。したがって、カドミウム以外は自主基準 が優先される。なお、製品分野や用途が当該法規の対象とならないことが明らかな場合は、自主基準を 適用する。 (5) 参考 URL http://ec.europa.eu/environment/waste/elv_index.htm (6) その他 chemSHERPA の成形品に関する情報伝達では、適用除外の該否およびその用途の報告を必要とす る。 3.1.4 LR04：EU RoHS 指令 2011/65/EU ANNEX II (1) 概要 欧州の電気・電子機器における特定有害物質の使用制限に関する指令(RoHS 指令)の Annex II で指定されている物質(群)。これらの物質(群)は同指令第 4 条で使用が制限（ただし、Annex III に 適用除外用途あり）されている。 (2) 更新 不定期。 (3) chemSHERPA での物質の区分 特になし（データ作成支援ツールでは、当該物質の LR04 の欄に“１”が表示される）。 (4) 法規における閾値と chemSHERPA の成分情報の閾値の考え方 法規においては、最大許容濃度が均質材料中の重量比で 0.1%(カドミウムは 0.01%)と定められてい る。 chemSHERPA の成分情報における閾値は、法規の閾値（カドミウムについては 0.01%、その他は 0.1%を超える場合を禁止）と自主基準のうち、小さい方である。なお、製品分野や用途が当該法規の 対象とならないことが明らかな場合は、自主基準を適用する。 (5) 参考 URL http://ec.europa.eu/environment/waste/rohs_eee/index_en.htm 6 3 管理対象物質 Ver2.02.00 について (6) その他 chemSHERPA の成形品に関する情報伝達では、適用除外の該否およびその用途の報告を必 要とする。 DEHP, BBP, DBP, DIBP の 4 物質については、適用日が 2019 年 7 月 22 日 (Category1 ～7,10,11), 2021 年 7 月 22 日(Category8,9)であるが、chemSHERPA の目的に鑑み、 適用日以前でも chemSHERPA 管理対象物質とする。 3.1.5 LR05：EU POPs 規則 (EU) 2019/1021 ANNEX I (1) 概要 残留性有機汚染物質(Persistent Organic Pollutants; POPs)に関するストックホルム条約の EU における担保法（ストックホルム条約締結加盟国は、対象となっている物質について、条約を担保できるよ うに国内法を整備することとなっている）である POPs 規則の ANNEX I に収載されている物質。これらの 物質は、原則製造、上市および使用が禁止される(適用除外規定あり)。 (2) 更新 不定期。POPs 条約で Annex に新たに物質が追加された場合、追加の通報から 1 年後に発効する。 (3) chemSHERPA での物質の区分 特になし（データ作成支援ツールでは、当該物質の LR05 の欄に“１”が表示される）。 (4) 法規における閾値と chemSHERPA の成分情報の閾値の考え方 原則禁止であり、閾値は定められていない。 chemSHERPA の成分情報の報告における閾値は“０”と考える。 (5) 参考 URL http://ec.europa.eu/environment/chemicals/international_conventions/index_en. htm 3.1.6 LR06：EU REACH 規則 (EC) No 1907/2006 Candidate List of SVHC for Authorisation（認可対象候補物質）および ANNEX XIV（認可対象物質） (1) 概要 EU における化学品の 登録・ 評価・ 認可および制限に 関 する規則(REACH; Registration,Evaluation, Authorisation and
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